Short-bevel non-coring needle

ABSTRACT

A non-coring needle for use in accessing an implanted medical device is disclosed. The non-coring needle is configured to include a compact bevel face relative to standard non-coring needles. In one embodiment, the non-coring needle comprises a hollow cannula that defines a lumen and terminates at a sharpened distal tip. The cannula includes a proximal portion and a bent distal portion. The distal portion defines a bevel face extending proximally from the distal tip, and the bevel face includes the lumen distal opening. The bevel face defines an open angle of at least about one degree with respect to a longitudinal axis of the proximal portion of the cannula. The bevel face is also laterally offset from the proximal portion of the cannula by an offset distance of no more than about 0.010 inch. A portion of the bevel face is dulled to prevent access port septum coring.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/213,467, filed Mar. 14, 2014, now U.S. Pat. No. 9,757,148, whichclaims the benefit of U.S. Provisional Patent Application No.61/798,676, filed Mar. 15, 2013, and is titled “Short-Bevel Non-CoringNeedle,” each of which is incorporated herein by reference in itsentirety.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toa non-coring Huber-type needle for use in accessing an implanted medicaldevice. The non-coring needle is configured so as to include a compactbevel face relative to standard non-coring needles.

In one embodiment, the non-coring needle comprises a hollow cannula thatdefines a lumen and terminates at a sharpened distal tip. The cannulaincludes a proximal portion and a bent distal portion. The distalportion defines a bevel face extending proximally from the distal tip,and the bevel face includes the lumen distal opening. The bevel facedefines an open angle of at least about one degree with respect to alongitudinal axis of the proximal portion of the cannula. The bevel faceis also laterally offset from the proximal portion of the cannula by anoffset distance of no more than about 0.010 inch. A portion of the bevelface is dulled to prevent access port septum coring. In addition, thecompact bevel face reduces the insertion profile of the needle, whichimproves patient comfort.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of embodiments of theinvention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is a perspective view of an infusion set according to oneembodiment;

FIGS. 2A-2E are various views of a distal portion of a needle accordingto one embodiment; and

FIG. 3 is a cross-sectional view of an access port being accessed byneedles, according to one embodiment.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale.

For clarity it is to be understood that the word “proximal” refers to adirection relatively closer to a clinician using the device to bedescribed herein, while the word “distal” refers to a directionrelatively further from the clinician. For example, the end of a needleplaced within the body of a patient is considered a distal end of theneedle, while the needle end remaining outside the body is a proximalend of the needle. Also, the words “including,” “has,” and “having,” asused herein, including the claims, shall have the same meaning as theword “comprising.”

Embodiments of the present invention are generally directed to anon-coring needle for use in accessing an internal portion of apatient's body, such as to access an access port subcutaneouslyimplanted within the patient, for instance, in order to delivermedicaments or other fluids to the patient, or to withdraw fluidstherefrom. In accordance with one embodiment, the non-coring needle isconfigured so as to include a relatively compact distal portion. Indeed,in one embodiment, the bevel face of the distal portion of the needle isminimized in longitudinal length and insertion profile as compared tostandard non-coring needles. This in turn enables the present needle tobe larger in gauge relative to standard needles having comparably sizedbevel faces, which correspondingly facilitates enhanced fluid flowthrough the needle.

Also, the shorter bevel face of the present needle assists in ensuringthe entire bevel face of the needle resides within the reservoir of anaccess port when the needle is inserted into the port. Note that theprinciples discussed herein can be applied to needles of a variety ofgauges and configurations, for use in various devices and with variousapplications. Note that, as used herein, a “Huber” or “Huber-type”needle is understood to include a non-coring needle that includes abeveled face at its distal end. The beveled face of the needle mayinclude one or more facets thereon.

Reference is first made to FIG. 1, which describes details of aneedle-based infusion set, generally designated at 10, as one exampleimplementation where embodiments of the present disclosure can bepracticed. As shown, the infusion set 10 includes a needle assembly 20,which in turn includes a needle hub 24 and a hollow needle 30 extendingtherefrom. The infusion set 10 further includes an extension leg 16 thatdefines a lumen that is in fluid communication with the needle 30 viathe needle hub 24. A connector, such as a luer connector 18, is includedon a proximal end of the extension leg 16 to enable the infusion set 10to be operably connected to a fluid source, such as a syringe, vial,etc., or to a fluid repository in the case of fluid aspiration from theport through the infusion set.

The hollow needle 30 includes a distal tip 30A, which is insertedthrough the skin of a patient in order to access an internal bodyportion or implanted device. In one embodiment, the implanted deviceincludes a subcutaneously disposed access port that is configured toestablish fluid communication with the vasculature of the patient. Whenthe distal tip 30A and distal portion of the infusion set needle 30 isoperably inserted into the port, fluids can be infused into and/oraspirated from the port via the infusion set 10 and needle. Of course,other uses for the needle and other medical devices to be accessed canbe contemplated. In one embodiment, for example, the needle 30 can beemployed to assist in placing a catheter, such as an insulin infusioncatheter, into the body of a patient.

Reference is now made to FIGS. 2A-2E in describing further detailsregarding the needle 30 in accordance with one embodiment. As shown, theneedle 30 includes a hollow shaft, or cannula 32. A proximal portion ofthe cannula 32 is substantially longitudinally straight, while a distalportion 34 having a bend length 44 (being measured along a y-axis of anx-y coordinate axis as shown in FIG. 2B) is bent with respect to theproximal portion at a bend 36. This results in the distal portion 34being disposed at a bend angle 37 with respect to the proximal portionof the cannula 32. The bent configuration of the cannula distal portion34 provides non-coring performance to the needle 30, similar toHuber-type needles. In one embodiment, the magnitude of the bend angle37 is about 13 degrees, though other angles are possible. For example,in one non-limiting embodiment, the bend angle of the distal portion canvary from about 9 degrees to about 17 degrees. The distal portion 34 ofthe needle cannula 32 terminates at a sharpened distal tip 30A of theneedle 30.

A terminal end of the needle cannula distal portion 34 defines a bevelface 40 that extends proximally from the needle distal tip 30A to definea bevel face length 42, the bevel face length being measured along they-axis of an x-y coordinate axis as shown in FIG. 2B. A distal opening38 of a lumen 52 (FIG. 2E) defined by the hollow cannula 32 is disposedon the bevel face 40. A chisel portion 46, including chisel faces 46A,is disposed adjacent the needle distal tip 30A to ease insertion of theneedle 30 into the skin of the patient. The chisel portion 46 includes achisel length 48, as measured along a y-axis of the x-y coordinate axisas shown in FIG. 2B.

As best seen in FIG. 2B, the bevel face 40 is angled to define an openbevel face angle 54, from a perspective at the distal end of the needle30 looking proximally toward the needle hub 24 (FIG. 1). Though it canvary according to needle size or gauge, in the illustrated embodimentthe magnitude of the bevel face angle 54 can be in the range of aboutone degree to about nine degrees, measured with respect to a lineparallel to the longitudinal axis of the proximal portion of the cannula32, such as an offset line 60 shown in FIG. 2B and discussed below.Again, other angles are possible. In the present embodiment, the bevelface angle 54 is about two degrees though, again, other angles arepossible. The effect of the open-angle nature of the bevel face angle 54can be seen in FIG. 2D, which shows the distal portion 34 of the needle30 as viewed straight down the cannula 32. The open-angle nature of thebevel face 40 contrasts with traditional Huber-type needle tip designs,which include closed-angle configurations.

To eliminate the potential for partial coring of an access port septumduring needle insertion (such coring otherwise potentially caused by thechisel faces 46A and the perimeter of the distal opening 38), a proximalportion 38A (FIGS. 2C, 2D), such as a proximal half, of the distalopening perimeter is dulled so as to prevent its ability to cut througha surface. In one embodiment, this is accomplished by bead blasting withglass or other suitable beads a dulling region 58 of the bevel face 40,which corresponds in the illustrated embodiment to approximately aproximal portion equaling about 75 percent of the bevel face length 42.Such a procedure is performed during manufacture of the needle 30. Inaddition, other dulling procedures may be performed on the dullingregion different from or in addition to bead blasting, and regionslarger or smaller than the dulling region indicated here may be treated.

As best seen in FIG. 2B, the bevel face 40 of the needle distal portion34 is laterally offset from the cannula 32 in a positive direction alongthe x-axis of the x-y coordinate axis as shown in FIG. 2B. This lateraloffset is indicated by an offset distance 50 in FIG. 2B, which ismeasured between the proximal end of the bevel face 40 (corresponding tooffset line 60, which runs parallel to both the longitudinal axis of theproximal portion of the cannula 32 and the y-axis of the x-y coordinateaxis shown in FIG. 2B) and the most proximate outer surface of theproximal portion of the cannula 32. The magnitude of the offset distance50 is minimized as compared to traditional Huber-type needle designs,which include larger lateral offsets. Minimization of the offsetdistance 50 in the manner shown in FIG. 2B further reduces thelongitudinal distance between the bend 36 and the top of the bevel face40, as well as the bend length 44. In the illustrated embodiment, themagnitude of the offset distance is about 0.005 inch, though this valuecan vary according to needle design, gauge size, etc. In anotherembodiment, the magnitude of the offset distance is about 0.010 inch.

In accordance with one embodiment, the above-described configuration ofthe distal portion 34 of the needle cannula 32 enables the size andlength 42 of the bevel face 40 to be smaller relative to the bevel facesof traditional Huber-type needles of the same gauge. In particular,minimization of the offset distance 50 in turn minimizes the length ofthe distal portion 34 of the needle distal to the bend 36. In addition,the open nature of the bevel face angle 54 provides a relatively largerdistal opening 38 for the lumen of the cannula. These features of theneedle 30 provide for a relatively large distal opening whilemaintaining a relatively small bevel face. Further, the minimization ofthe offset distance 50, together with the open bevel face angle 54 ofthe bevel face 40 discussed further above, desirably reduces thefootprint, or profile, of the needle 30, as seen from the perspectiveshown in FIG. 2D. This in turn desirably reduces the perceived size ofthe needle 30.

The result of the above-described configuration of the needle distalportion 34 and bevel face 40 can be seen in FIG. 3, which depicts anaccess port 70 suitable for implantation into a body of a patient. Asshown, the access port 70 includes a body 72 and a septum 74 thatcooperate to define a fluid reservoir 76 with a bottom surface 76A. Astem 78 extends from the port 70 and is in fluid communication with thereservoir 76 to provide an outlet/inlet thereto.

The needle 30 described above in connection with FIGS. 2A-2E is showninserted into the port 70 so as to pierce the septum 74 and seat in thereservoir 76 so that the entire bevel face 40 is disposed in thereservoir. A traditional Huber-type needle 90 is also shown similarlyinserted into the port 70. The gauge size of the needle 30 is largerrelative to the gauge size of the traditional needle 90. Nevertheless,the bevel faces of both needles are suitably disposed within thereservoir 76 so that fluid aspiration/infusion can occur withoutdifficulty. This shows the ability of the present needle to desirablyprovide a relatively larger needle—with its corresponding relativelyhigher fluid flow rate—without a corresponding substantial increase inbevel face size. Correspondingly, the present needle 30 can be sized soas to provide the same needle gauge as a traditional Huber-type needlebut with a relatively smaller bevel face, which in turn enables thereservoir of the access port to be smaller than what would otherwise bepossible, thus desirably reducing the overall height of the access port.

In one embodiment, a process for manufacturing the needle 30 includesfirst rolling and drawing a metal tube to form the cannula 32, whichcannula is then cut to desired length. A distal segment of the cannula32 is then bent with respect to the proximal portion thereof to form thedistal portion 34. The bevel face 40 is then ground to impart to thebevel face the open bevel face angle 54. The chisel faces 46A of thechisel portion 46 are then defined by grinding. The dulling region 58 ofthe bevel face 40 is then bead blasting with glass beads or othersuitable media to dull the proximal portion 38A (e.g., the proximalhalf) of the distal opening 38. Note that the above process steps can beperformed in a different order than what is given, andadditional/alternative steps can be included.

In one embodiment, the needle 30 includes a gauge size of 18, a bendangle 37 of about 13 degrees, a bevel face length 42 of about 0.186inch, a bend length 44 of about 0.196 inch, a chisel length 48 of about20 percent to about 30 percent of the bevel face length, a bevel faceangle 54 of about two degrees, and an offset distance 50 of about 0.005inch.

In another embodiment, the needle 30 includes a gauge size of 22, a bendangle 37 of about 13 degrees, a bevel face length 42 of about 0.107inch, a bend length 44 of about 0.119 inch, a chisel length 48 of about20 percent to about 30 percent of the bevel face length, a bevel faceangle 54 of about 2.5 degrees, and an offset distance 50 of about 0.005inch.

In another embodiment, the needle 30 includes a gauge size of 23, a bendangle 37 of about 13 degrees, a bevel face length 42 of about 0.094inch, a bend length 44 of about 0.108 inch, a chisel length 48 of about20 percent to about 30 percent of the bevel face length, a bevel faceangle 54 of about 2.5 degrees, and an offset distance 50 of about 0.005inch.

In one embodiment, the needle 30 includes a gauge size of 25, a bendangle 37 of about 13 degrees, a bevel face length 42 of about 0.076inch, a bend length 44 of about 0.093 inch, a chisel length 48 of about20 percent to about 30 percent of the bevel face length, a bevel faceangle 54 of about 2.5 degrees, and an offset distance 50 of about 0.005inch. Note that the above dimensions for the different gauges of theneedle 30 can vary and so should be understood as merely examples of theprinciples taught herein.

Embodiments of the invention may be embodied in other specific formswithout departing from the spirit of the present disclosure. Thedescribed embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the embodiments is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A Huber-type needle, comprising: a hollow cannulaincluding a substantially straight proximal portion and a bent distalportion, the bent distal portion defining a bevel face, the bevel faceincluding a distal opening of the cannula, the bevel face defining anopen angle of at least about one degree with respect to a line parallelto a longitudinal axis of the proximal portion of the cannula, wherein:the bevel face is laterally offset from the proximal portion of thecannula by an offset distance of no more than about 0.010 inch, and atleast a proximal half of a perimeter of the distal opening on the bevelface includes a dulled portion.
 2. The needle according to claim 1,wherein the dulled portion includes 75% of a length of the bevel face.3. The needle according to claim 2, wherein the dulled portion isproduced via a bead blasting process.
 4. The needle according to claim1, wherein the offset distance is about 0.005 inch.
 5. The needleaccording to claim 1, wherein the needle is part of an infusion set, theinfusion set including a needle hub and an extension leg in fluidcommunication with the needle.